MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombus (2101); Ventricular Fibrillation (2130); Injury (2348); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Age: average age.Sex: majority gender.Date of event: date of publication journal article title: thin composite-wire-strut zotarolimus-eluting stents versus ultrathin-strut sirolimus-eluting stents in bionyx at 2 years doi.Org/10.1016/j.Jcin.2020.01.230.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this bionyx study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer resolute onyx zotarolimus-eluting stent (zes), compared with the ultrathin strut biodegradable-polymer orsiro sirolimus-eluting stent (ses) in all-comers and a pre-specified small-vessel subgroup analysis.The bionyx study is an international, prospective, investigator-initiated, patient- and assessor blinded, randomized non-inferiority trial.A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in belgium, israel, and the netherlands from oct ober 2015 to december 2016.Patients were randomly assigned (1:1) to zes or ses, which were available in diameters ranging for zes from 2.0 to 5.0 mm and for ses from 2.25 to 4.0 mm.Follow-up was available in 2,460 of 2,488 patients (98.9%).Clinical outcomes included all cause death, cardiac death, target vessel¿related mi, clinically indicated target vessel revascularization and stent thrombosis.There were no significant between-stent differences in the incidence of the individual tvf (target vessel failure) components of cardiac death, target vessel¿related mi, and clinically indicated target vessel revascularization.In both groups, the use of dual-antiplatelet therapy at 2 years was low (15.2% vs 14.7%) as was the incidence of definite or probable stent thrombosis.The main endpoint, tvf, occurred in 93 of 1,243 patients (7.6%) assigned to zes.It was stated that results for the main endpoint were consistent across various subgroups.Adverse clinical event rates in these small vessel patient cohort were similar to rates in the entire study population.It was also stated that in the resolute onyx zes cohort, the 2-year definite stent thrombosis rate was 0.4%.

Manufacturer Narrative

Additional information: average patient weight provided it was later reported that there were 12 cardiac deaths in the patient group with resolute onyx stents, of which none had definite stent thrombosis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

There is no known relationship between the resolute onyx and the deaths.However, for 10 cases the cause of death was unknown or documented as ventricular fibrillation.There was 1 case of very late stent thrombosis in a resolute onyx stent.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10078915
• MDR Text Key: 200397639
• Report Number: 9612164-2020-01939
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 05/22/2020; 04/02/2021
• Supplement Dates FDA Received: 06/09/2020; 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 85